H. R. 1503 

One Hundred Sixteenth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Friday, 

the third day of January, two thousand and twenty 

An Act 

To amend the Federal Food, Drug, and Cosmetic Act regarding the list under 

section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Orange Book Transparency 

Act of 2020’’. 

SEC. 2. ORANGE BOOK MODERNIZATION. 

(a) SUBMISSION OF PATENT INFORMATION FOR BRAND NAME

DRUGS.— 

(1) IN GENERAL.—Paragraph (1) of section 505(b) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is 

amended to read as follows: 

‘‘(b)(1)(A) Any person may file with the Secretary an application 

with respect to any drug subject to the provisions of subsection 

(a). Such persons shall submit to the Secretary as part of the 

application— 

‘‘(i) full reports of investigations which have been made 

to show whether such drug is safe for use and whether such 

drug is effective in use; 

‘‘(ii) a full list of the articles used as components of such 

drug; 

‘‘(iii) a full statement of the composition of such drug; 

‘‘(iv) a full description of the methods used in, and the 

facilities and controls used for, the manufacture, processing, 

and packing of such drug; 

‘‘(v) such samples of such drug and of the articles used 

as components thereof as the Secretary may require; 

‘‘(vi) specimens of the labeling proposed to be used for 

such drug; 

‘‘(vii) any assessments required under section 505B; and 

‘‘(viii) the patent number and expiration date of each patent 

for which a claim of patent infringement could reasonably be 

asserted if a person not licensed by the owner of the patent 

engaged in the manufacture, use, or sale of the drug, and 

that— 

‘‘(I) claims the drug for which the applicant submitted 

the application and is a drug substance (active ingredient) 

patent or a drug product (formulation or composition) 

patent; or 

‘‘(II) claims a method of using such drug for which 

approval is sought or has been granted in the application. 
H. R. 1503—2 

‘‘(B) If an application is filed under this subsection for a drug, 

and a patent of the type described in subparagraph (A)(viii) is 

issued after the filing date but before approval of the application, 

the applicant shall amend the application to include the patent 

number and expiration date.’’. 

(b) SUBSEQUENT SUBMISSION OF PATENT INFORMATION.— 

(1) IN GENERAL.—Section 505(c)(2) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355(c)(2)) is amended— 

(A) by inserting before the first sentence the following: 

‘‘Not later than 30 days after the date of approval of an 

application submitted under subsection (b), the holder of 

the approved application shall file with the Secretary the 

patent number and the expiration date of any patent 

described in subsection (b)(1)(A)(viii), except that a patent 

that is identified as claiming a method of using such drug 

shall be filed only if the patent claims a method of use 

approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval 

of an application submitted under subsection (b), the holder 

of the approved application shall, not later than 30 days 

after the date of issuance of the patent, file the patent 

number and the expiration date of the patent, except that 

a patent that claims a method of using such drug shall 

be filed only if approval for such use has been granted 

in the application.’’; 

(B) in the first sentence following the sentences added 

by subparagraph (A), by striking ‘‘which claims the drug 

for which’’ and all that follows through ‘‘of the drug.’’ and 

inserting ‘‘described in subsection (b)(1)(A)(viii).’’; 

(C) in the second sentence following the sentences 

added by subparagraph (A), by inserting after ‘‘could not 

file patent information under subsection (b) because no 

patent’’ the following: ‘‘of the type for which information 

is required to be submitted in subsection (b)(1)(A)(viii)’’; 

and 

(D) by adding at the end the following: ‘‘Patent information that is not the type of patent information required 

by subsection (b)(1)(A)(viii) shall not be submitted under 

this paragraph.’’. 

(2) UPDATING LIST.—Clause (iii) of section 505(j)(7)(A) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) 

is amended by striking ‘‘(b) or’’. 

(c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) of section 

505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)) is amended by adding at the end the following: 

‘‘(iv) For each drug included on the list, the Secretary shall 

specify any exclusivity period that is applicable, for which the 

Secretary has determined the expiration date, and for which such 

period has not yet expired, under— 

‘‘(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E); 

‘‘(II) clause (iv) or (v) of paragraph (5)(B); 

‘‘(III) clause (ii), (iii), or (iv) of paragraph (5)(F); 

‘‘(IV) section 505A; 

‘‘(V) section 505E; 

‘‘(VI) section 527(a); or 

‘‘(VII) subsection (u).’’. 
H. R. 1503—3 

(d) ORANGE BOOK UPDATES WITH RESPECT TO INVALIDATED

PATENTS.— 

(1) AMENDMENT.—Section 505(j)(7) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by 

adding at the end the following: 

‘‘(D) In the case of a listed drug for which the list under 

subparagraph (A)(i) includes a patent for such drug, and any claim 

of the patent has been cancelled or invalidated pursuant to a 

final decision issued by the Patent Trial and Appeal Board of 

the United States Patent and Trademark Office or by a court, 

from which no appeal has been, or can be, taken, if the holder 

of the applicable application approved under subsection (c) determines that a patent for such drug, or any patent information 

for such drug, no longer meets the listing requirements under 

this section— 

‘‘(i) the holder of such approved application shall notify 

the Secretary, in writing, within 14 days of such decision of 

such cancellation or invalidation and request that such patent 

or patent information, as applicable, be amended or withdrawn 

in accordance with the decision issued by the Patent Trial 

and Appeal Board or a court; 

‘‘(ii) the holder of such approved application shall include 

in any notification under clause (i) information related to such 

patent cancellation or invalidation decision and submit such 

information, including a copy of such decision, to the Secretary; 

and 

‘‘(iii) the Secretary shall, in response to a notification under 

clause (i), amend or remove patent or patent information in 

accordance with the relevant decision from the Patent Trial 

and Appeals Board or court, as applicable, except that the 

Secretary shall not remove from the list any patent or patent 

information before the expiration of any 180-day exclusivity 

period under paragraph (5)(B)(iv) that relies on a certification 

described in paragraph (2)(A)(vii)(IV).’’. 

(2) APPLICABILITY.—Subparagraph (D) of section 505(j)(7) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), as added by paragraph (1), applies only with respect 

to a decision described in such subparagraph that is issued 

on or after the date of enactment of this Act. 

(e) REVIEW AND REPORT.—Not later than 1 year after the date 

of enactment of this Act, the Secretary of Health and Human 

Services, acting through the Commissioner of Food and Drugs, 

shall— 

(1) solicit public comment regarding the types of patent 

information that should be included on, or removed from, the 

list under section 507(j)(7) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(j)(7)); and 

(2) transmit to Congress a summary of such comments 

and actions the Food and Drug Administration is considering 

taking, if any, in response to public comment pursuant to 

paragraph (1) about the types of patent information that should 

be included or removed from such list. 

(f) GAO REPORT TO CONGRESS.— 

(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of this Act, the Comptroller General of the United 

States (referred to in this section as the ‘‘Comptroller General’’) 

shall submit to the Committee on Health, Education, Labor, 
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and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives a report on 

the patents included in the list published under section 505(j)(7) 

of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(7)) 

that claim an active ingredient or formulation of a drug in 

combination with a device that is used for delivery of such 

drug, including an analysis of such patents and their claims. 

(2) CONTENT.—The Comptroller General shall include in 

the report under paragraph (1)— 

(A) data on— 

(i) the number of patents included in the list published under section 505(j)(7) of the Federal Food, Drug 

and Cosmetic Act (21 U.S.C. 355(j)(7)) that claim the 

active ingredient or formulation of a drug in combination with a device that is used for delivery of the 

drug, and that together claim the finished dosage form 

of the drug; and 

(ii) the number of claims with respect to each 

patent included in the list published under such section 

505(j)(7) that claim a device that is used for the 

delivery of the drug, but do not claim such device 

in combination with an active ingredient or formulation 

of a drug; 

(B) an analysis of the listing of patents described in 

subparagraph (A)(ii), including the timing of listing such 

patents in relation to patents described in subparagraph 

(A)(i), and the effect listing the patents described in 

subparagraph (A)(ii) has on market entry of one or more 

drugs approved under section 505(j) of the Federal Food, 

Drug, and Cosmetic Act as compared to the effect of not 

listing the patents described in subparagraph (A)(ii); and 

(C) recommendations about which kinds of patents 

relating to devices described in subparagraph (A)(i) should 

be submitted to the Secretary of Health and Human Services for inclusion on the list under section 505(j)(7) of 

the Federal Food, Drug, and Cosmetic Act and which patents should not be required to be so submitted in order 

to reduce barriers to approval and market entry. 

(g) CONFORMING AMENDMENTS.—Section 505 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 

(1) in subsection (c)(3)(E), by striking ‘‘clause (A) of subsection (b)(1)’’ each place it appears and inserting ‘‘subsection 

(b)(1)(A)(i)’’; and 
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(2) in subsection (j)(2)(A)(vi), by striking ‘‘clauses (B) 

through (F) of subsection (b)(1)’’ and inserting ‘‘clauses (ii) 

through (vi) of subsection (b)(1)(A)’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.